# K081858: Retcam 3 Ophthalmic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Clarity Medical Systems
- Decided: Nov 5, 2008 after 127 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K083771: Retcam Portable Ophthalmic Imaging System, Model RCP (2009), 8 descendants of its own
- K090326: Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems (2009), 7 descendants of its own
- K102859: Retcam 3 Opthalmic Imaging System (2011), 4 descendants of its own
- K170527: Phoenix Clinical ICON (2017), 3 descendants of its own
- K183059: 3nethra neo (2018), 1 descendant of its own

## Recalls of this device
- Mar 7, 2014 · Class II · Z-1265-2014: One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer mo
- Jan 24, 2014 · Class II · Z-1154-2014: Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
- Feb 2, 2012 · Not classified · Z-1099-2012: Still images extracted from video recordings may be mislabeled as to right and left eye.

Source page: https://510kreport.com/device/K081858
Methodology: https://510kreport.com/methodology